E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Glaucoma; elevated Intraocular Pressure (IOP) |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018304 |
E.1.2 | Term | Glaucoma |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to demonstrate that the IOP lowering efficacy of Travoprost Ophthalmic Solution, 0.003% is equivalent to TRAVATAN® in patients with open-angle glaucoma or ocular hypertension. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion Criteria:
1. Patients 18 years of age or older
2. Diagnosis of open-angle glaucoma (including open-angle
glaucoma with pseudoexfoliation or pigment dispersion)
or ocular hypertension.
3. Qualifying mean IOP (after washout) at both the
Eligibility 1 and 2 Visits in at least 1 eye (the same eye)
must be:
• ≥ 24 mmHg at the 8 AM (± 30 minutes) time point
and,
• ≥ 21 mmHg at the 10 AM (± 30 minutes) and 4 PM
(± 30 minutes) time points.
Mean IOP must be ≤ 36 mmHg at all time points, OU.
Note: Mean IOP is the average of 2 successive IOP
measurements in the same eye, as described in the Manual
of Procedures. A third measurement is required if the first
2 measurements differ by more than 4 mmHg.
4. Must be able to understand and sign an informed consent
form that has been approved by an Institutional Review
Board/Independent Ethics Committee.
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E.4 | Principal exclusion criteria |
1. Women of childbearing potential (ie, those who are not postmenopausal for at least 1 year or surgically sterile) are excluded from participation if they are currently pregnant, have a positive result on the urine pregnancy test at Screening, or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy
throughout the study.
Related to disease/condition being investigated (either eye)
2. Modified Shaffer angle grade < 2 as measured by
gonioscopy (extreme narrow angle with complete or
partial closure).
3. Cup/disc ratio (C/D) greater than 0.80 (horizontal or
vertical measurement).
4. Severe central visual field loss defined as a sensitivity
≤ 10 dB in at least 2 of the 4 visual field test points closest
to the point of fixation.
5. Patients who in the opinion of the Investigator cannot
discontinue all IOP-lowering ocular medication(s) per the
appropriate washout schedule prior to the E1 Visit.
Excluded from participation if they are currently pregnant,
have a positive result on the urine pregnancy test at
Screening, or intend to become pregnant during the study
period; are breast-feeding; or are not in agreement to use
adequate birth control methods to prevent pregnancy
throughout the study.
Related to disease/condition being investigated (either eye)
2. Modified Shaffer angle grade < 2 as measured by
gonioscopy (extreme narrow angle with complete or
partial closure).
3. Cup/disc ratio (C/D) greater than 0.80 (horizontal or
vertical measurement).
4. Severe central visual field loss defined as a sensitivity
≤ 10 dB in at least 2 of the 4 visual field test points closest
to the point of fixation.
5. Patients who in the opinion of the Investigator cannot
discontinue all IOP-lowering ocular medication(s) per the
appropriate washout schedule prior to the E1 Visit.
Related to previous or current ocular disease/condition
(either eye)
6. History of chronic, recurrent or severe inflammatory eye
disease (ie, scleritis, uveitis, herpes keratitis).
7. Ocular trauma requiring medical attention within the past
6 months prior to the Screening Visit.
8. Ocular infection or ocular inflammation within the past
3 months prior to the Screening Visit.
9. Clinically significant or progressive retinal disease such as
retinal degeneration, diabetic retinopathy, or retinal
detachment.
10. Best-corrected visual acuity (BCVA) score worse than
55 ETDRS letters (equivalent to approximately 0.60
logMAR, 20/80 Snellen, or 0.25 decimal).
11. Other severe ocular pathology (including severe dry eye),
in the opinion of the Investigator, that would preclude the
administration of a topical prostaglandin analog.
12. Intraocular surgery within the past 6 months prior to the
Screening Visit.
13. Ocular laser surgery within the past 3 months prior to the
Screening Visit.
14. Any abnormality preventing reliable applanation tonometry.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Efficacy
• IOP at Week 2, Week 6, and Month 3 for each time point (8 AM, 10 AM and 4 PM) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 2, Week 6, and Month 3 for each time point (8 AM, 10 AM and 4 PM) |
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E.5.2 | Secondary end point(s) |
• IOP change from baseline and IOP percent change from baseline at each visit (Week 2, Week 6, and Month 3) and time point (8 AM, 10 AM and 4 PM).
• Percentage of patients who achieve a target IOP level < 18 mmHg at each visit (Week 2, Week 6, and Month 3) and time point (8 AM, 10 AM and 4 PM).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
at each visit (Week 2, Week 6, and Month 3) and time point (8 AM, 10 AM and 4 PM). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Belgium |
Germany |
Hungary |
Israel |
Italy |
Mexico |
Netherlands |
Spain |
Sweden |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last Patient Last Visit is defined as the end of the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |